Weight: 5.00 oz. Fully covered, partially covered and uncovered WallFlex Biliary RX Stents are available in multiple sizes to accommodate different anatomical and clinical requirements. 138 0 obj<>stream risk assessment underpinning this policy can be found here: This policy does not cover the use of MRI on patients with biliary stents that have been inserted outwith GRI, RAH and QEUH department, Additional background Advanix BiliaryStent with NaviFlex RX Delivery System Why place a stent? Removability Find products, medical specialty information, and education opportunities. 0000001096 00000 n Applicant Contact: ELENA NIEVES: Correspondent: BOSTON SCIENTIFIC CORP. 100 BOSTON SCIENTIFIC WAY: MARLBOROUGH, MA 01752 Correspondent . Brand Name: Advanix Pancreatic Stent Commercial Distribution Status: In Commercial Distribution Company Name: BOSTON SCIENTIFIC CORPORATION Primary DI Number: 08714729857792 Issuing Agency: GS1 Commercial Distribution End Date: NA Device Count: 1 Device Description: Pancreatic Stent Advanix Pancreatic Stent - Device Characteristics Cochrane Database Systematic Review, 25 Jan. 2006. The Advanix Biliary Stent and NaviFlex RX Delivery System are available in a variety of options: RX pre-loaded systems, singles, multiple sizes and shapes to accommodate physician preferences, different disease states and patient anatomies. boston scientific emerge stent mri safety. This represents the first metal biliary stent in the United States which has been cleared for use in the treatment of benign biliary strictures secondary to chronic pancreatitis. Neuroform Atlas Stent Non-clinical testing and analysis have demonstrated that the Neuroform Atlas Stent is MR Conditional alone, or when overlapped with a second stent, and adjacent to a Stryker Neur Learn more about solutions for your specialty area, Device setup, user manuals and troubleshooting. 0000003412 00000 n PLEASE REFER TO THE LABELING FOR A MORE COMPLETE LIST OF WARNINGS, PRECAUTIONS AND CONTRAINDICATIONS. Find products, medical specialty information, and education opportunities. Boston Scientific Corporation. 3: Safe More. CAUTION: The law restricts these devices to sale by or on the order of a physician. 0000000016 00000 n Polymeric biliary stent, non-bioabsorbable Polymeric biliary stent, non-bioabsorbable Polymeric biliary stent, . Polymeric biliary stent, non-bioabsorbable. HW[%~_fLF^&II6ZjKNw~?k_<=5ZoKrdO&]L,o/$_otBM=n]oDbe. In previous cases, MBS occurred in 72% of patients with biliary stricture. Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. When a blockage occurs in the bile duct, fluids like bile (bilirubin) are unable to flow into the duodenum to aid in digestion. First; Previous; . LIMITATIONS Radial force helps maintain stent patency and resist migration. 0 It is made entirely of a synthetic polymer(s) [e.g., polytetrafluoroethylene (PTFE), polyethylene (PE), silicone] and may have various designs (e.g., continuous tube with or without drainage side holes, covered or non-covered mesh structure). Boston Scientific is a worldwide developer, manufacturer and marketer of medical devices whose . Boston Scientific - THE IMPLANT REGISTER Boston Scientific unregistered register now see also: IMPLANTS USA contact n/a This is a post of a nonregistered company. These stents may be used with short or long guidewires. It is made entirely of a synthetic polymer(s) [e.g., polytetrafluoroethylene (PTFE), polyethylene (PE), silicone] and may have various designs (e.g., continuous tube with or without drainage side holes, covered or non-covered mesh structure). Device Name. Find out who we are, explore careers at the company, and view our financial performance. This product line is serviced by the following clinical division (s): Endoscopy The products on this website are available for sale in the United States. The Advanix Biliary Stent with NaviFlex RX Delivery System is designed to maximize flow rates, improve pushability through tortuous anatomy, and be repositionable to aid in accurate placement. All rights reserved. 0000002795 00000 n 0000014680 00000 n 043254. Brand Name: Advanix Biliary Version or Model: M00534320 Commercial Distribution Status: In Commercial Distribution Catalog Number: Company Name: BOSTON SCIENTIFIC CORPORATION Primary DI Number: 08714729787419 Issuing Agency: GS1 Commercial Distribution End Date: Device Count: 1 Labeler D-U-N-S Number*: 021717889 * Terms of Use The Program is subject to modification or termination by Boston Scientific without prior notification. It is made entirely of a synthetic polymer(s) [e.g., polytetrafluoroethylene (PTFE), polyethylene (PE), silicone] and may have various designs (e.g., continuous tube with or without drainage side holes, covered or non-covered mesh structure). A thorough understanding of the technical principles, clinical applications, and risks associated with endoscopic biliary stent procedures is necessary before using this . Brand Name: Advanix Biliary. Boston Scientific Corporation 100 Boston Scientific Way Marlborough, MA 01752 Telephone: 508-683-4347 Fax: 508-683-5939 . 0000003219 00000 n Disposable devices intended to assist implantation may be included. Catalog Number: Company Name: BOSTON SCIENTIFIC CORPORATION Primary DI Number: 08714729856214 Issuing Agency: GS1 Commercial Distribution End Date: Device Count: 1 Labeler D-U-N-S Number*: 021717889 * Terms of Use Device Description: RX Pusher CLOSE Device Characteristics Device Record Status Alternative and Additional Identifiers Customer Contact The data demonstrate that the Advanix Double The four fluoroscopy markers and yellow transition zone are designed to help aid in stent placement accuracy when deployed using endoscopic visualization. The Advanix Biliary Stent with NaviFlex RX Delivery System is designed to maximize flow rates, improve pushability through tortuous anatomy, and be repositionable to aid in accurate placement. Boston, MA. All rights reserved. Company Name: BOSTON SCIENTIFIC CORPORATION. The fully covered stent is indicated for indwell up to 12 months after placement in benign biliary strictures secondary to chronic pancreatitis. 0000003307 00000 n BBS is generally caused by injury to the bile duct or benign biliary disease, while MBS is generally the result of malignant bile duct tumors. In the United States, the WallFlex Biliary RX Fully Covered Stent System RMV is cleared for indwell up to 12 months in the treatment of benign biliary strictures secondary to chronic pancreatitis. Marlborough, MA 01752. To aid in placement, the stent is constructed of a flexible yet durable polymer. 0000010863 00000 n Applicant. However, it has been found that the make and model of the stent is typically omitted in surgical notes, making it difficult to determine the MR safety status. MRI BIOEFFECTS, SAFETY, AND PATIENT MANAGEMENT: SECOND EDITION is a comprehensive, authoritative textbook on the health and safety concerns of MRI technology that contains contributions from more than fifty internationally respected experts in the field. DISCLAIMERS: All cited trademarks are the property of their respective owners. Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. endstream endobj 100 0 obj<> endobj 101 0 obj<>/Shading<>/ColorSpace<>/Font<>/ProcSet[/PDF/Text/ImageC]/ExtGState<>>>/Type/Page>> endobj 102 0 obj<> endobj 103 0 obj[/Separation/PANTONE#203145#20C/DeviceCMYK 131 0 R] endobj 104 0 obj[/Separation/PANTONE#203145#20C/DeviceCMYK 129 0 R] endobj 105 0 obj<> endobj 106 0 obj<> endobj 107 0 obj<> endobj 108 0 obj<> endobj 109 0 obj<> endobj 110 0 obj<> endobj 111 0 obj<>stream Cotton-Leung Biliary Stent only | Cook Medical Cotton-Leung Biliary Stent only Documents Images Used to drain obstructed biliary ducts. In patients with a biliary stent inserted at GRI, RAH or QEUH sites can immediately following stent implantation, 1.5T or 3T MRI can safely proceed using the Normal Operating Mode of the scanner. Must read: What this policy does not cover / notable exceptions, This policy does not cover the use of MRI on patients with biliary stents that have been inserted outwith GRI, RAH and QEUH departments. Maximized Lumenal Integrity Thin wall design for maximized inner diameter - full length of stent designed to maximize flow rates and help reduce clogging Improved Deliverability Tapered stent tip design to . The Advanix Biliary Stent will be will be offered in 7Fr, 8.5Fr, and lOFr diameters. Soderlund K., Linder S.; Covered metal versus plastic stents for malignant common bile duct stenosis: a prospective, randomized, controlled trial. 0000194782 00000 n 0000027207 00000 n Testing of overlapped stents has not been conducted. CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician. Introducer components sold separately. All consumers or patients are advised to consult their doctor or physician for advice on medical devices or any health related matters. ` X Drainage holes are positioned every 5mm at 90 degree intervals to support drainage and patency. 0000022971 00000 n ** In the event of incorrect positioning during the initial stent placement procedure, the partially covered and fully covered stent options may be removed using forceps to grasp the retrieval loop on the end of the stent. MRI Safety Status: MR Safe: Human Cell/Tissue Product: false: Device Kit: false: Device Combination Product: During two routine follow ups in the clinic after plastic stent placement, it was reported that the patient came in with pain in the middle of the night and showed that the stent had migrated into the sigmoid colon and had a perforation. Endoscopic Placement Maple Grove, M. 3: Safe More. 0000194996 00000 n Warnings: The safety and effectiveness of the stent has not been established for indwell periods exceeding 12 months. CAUTION: Federal Law (USA) restricts these devices to sale by or on the order of a physician. The Advanix Biliary Stent preloaded with NaviFlex RX Delivery System is designed to maximize flow rates, improve pushability through tortuous anatomy, and be repositionable to aid in accurate placement. The indications for pancreatic stent implantation are either prophylactic or MRI Information for Healthcare Professionals - Boston Scientific Customer support MRI Information MRI Information For Healthcare Professionals For specific information about a Boston Scientific product's MR safety status, please refer to the product's Instructions For Use or contact Boston Scientific Customer Service. Flexima Duodenal Bend Biliary Stent with Delivery System 23 Advanix Pancreatic Stent Kit - Pigtail, Leading Barb and . Boston Scientific is committed to providing updated medical information on its products, to healthcare professionals, which is in compliance with Indian regulations. All rights reserved. 0000006359 00000 n DISCLAIMERS: Please note that access to certain information on the following pages is intended for healthcare professionals. For health care professionals in EUROPE excepted those practicing in France as the following pages are intended to all International health care professionals and are not in compliance with the French Advertising law N2011-2012 dated 29th December 2011 article 34. The stent was . The hospital is responsible for reporting the replacement stent as a discount on the hospitals cost report. Closed cell construction and Permalume covered options designed to help resist tissue in-growth.1,2. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. Information given here is checked thoroughly by "Implant-Register". Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. BOSTON SCIENTIFIC BOSTON SCIENTIFIC Lead Pacemaker ICD S-ICD SEARCH / FILTERING ACCOLADE (L310, L311, L331) Field strength 1,5T full body 3T full body Exclusion zone No exclusion zone Specific conditions In combinaison with Boston Scientific compatible MRI leads Last update Tuesday, 25 October 2022 ACUITY SPIRAL (4591, 4592, 4593) Field strength EGIS@ Biliary Stent consists of 4 type of style named Single Bare,Single Covered, Double Bare, Double Covered and Catheter which guides the Stent to the disease region. This is the definitive textbook on MRI safety for radiologists and other physicians, MRI technologists, physicists, scientists, MRI facility . xb``c``ig`e`bd@ A6v[*/`` j[rc 0000032536 00000 n United States Latin America Europe, Middle East & Africa Asia-Pacific What does EDUCARE offer? 2023 Boston Scientific Corporation or its affiliates. The sale, distribution, and use of the device are restricted to prescription use in Find out who we are, explore careers at the company, and view our financial performance. The Advanix Biliary Stent and NaviFlex RX Delivery System are available in a variety of sizes and shapes to accommodate both malignant and benign biliary strictures, distinct patient anatomies and physician preferences. 2023 Boston Scientific Corporation or its affiliates. Boston Scientific Advanix biliary stents win FDA, CE mark . Please check availability with your local sales representative or customer service. Refer to package insert provided with the product for complete Indications for Use, Contraindications, Warnings, Precautions, and Adverse Events prior to using this product. Intended Use/Indications for Use: The WallFlex Biliary RX Stents are indicated for use in the palliative treatment of biliary strictures produced by malignant neoplasms. DISCLAIMERS: INDICATIONS FOR USE in the United States: Endo-232507-AA April 2014, Advanix Biliary Stent with NaviFlex RX Delivery System, View Ordering Information for Advanix Duodenal Bend Preloaded RX Stent Systems, View Ordering Information for Advanix Center Bend Preloaded RX Stent Systems, View Ordering Information for Advanix Duodenal Bend - Single Stent, View Ordering Information for Advanix Center Bend - Single Stent, View Ordering Information for Advanix Double Pigtail - Single Stent, View Ordering Information for NaviFlex Rx Delivery System*. The stent contains nickel, which may cause an allergic reaction in individuals with nickel sensitivity. With endoscopic and radiopaque markers 1 for enhanced visualization 2, the Advanix Pancreatic Stent helps facilitate stent placement during procedure and at follow-up fluoroscopic examination. Stents are not a magnetic resonance imaging (MRI) contrast medium. Other health care professionals should select their country in the top right corner of the website. Donelli, G, MD, et. Coils, Filters, Stents, and Grafts More. trailer Introduction Stenting of the pancreas is a challenging task for the interventional gastroenterologist. Device Name: Biliary Stent with NaviflexTM RX Delivery System. Coils, Filters, Stents, and Grafts More . 2023 Boston Scientific Corporation or its affiliates. Zimmon Biliary Stent Sets Specifications Documents Images Used to drain obstructed biliary ducts. All rights reserved. See all healthcare professional information, Lab Agent - restock products for your practice, Bladder leakage and pelvic organ prolapse, Enteral feeding tube and esophageal stent device support, Cardiac Resynchronization Therapy (CRT) device support, Peripheral Artery and Vein interventions device support, Transcatheter Aortic Valve Replacement device support, Spinal Cord Stimulator (SCS) systems device support, EDUCARE Medical Education and Training Courses, ADVANTICS Innovative Healthcare Solutions, Do not sell or share my personal information. It was reported that an advanix biliary stent was implanted in the patient on an unknown date. Premarket Submission Number Not Available/Not Released, Device Size Text, specify: 3.3 mm Stent Diameter, Device Size Text, specify: 7 cm Effective Length, Device Size Text, specify: 10 F Stent Diameter. Warning: No warranty is made with regard to removability of this device by endoscopic means or otherwise. %%EOF Advanix Pancreatic Stent and NaviFlex RX Pancreatic Delivery System, and NaviFlex Pushers Available in a variety of French sizes and lengths. 510 (k) Number. 0000032476 00000 n Claims under the Program are limited to a replacement stent. The delivery system Stent Placement Accuracy Data claim does not apply to the 3Fr stent. The WallFlex Biliary RX Fully Covered Stent System RMV is currently the only biliary metal stent in the U.S. for indwell up to 12 months in the treatment of benign biliary strictures secondary to chronic pancreatitis. Are you a Medical Device Company? 0000005372 00000 n %PDF-1.4 % FDA.report GUDID BOSTON SCIENTIFIC CORPORATION 08714729786825. Fluoroscopic Visualization The patient should not be exposed to a magnetic field. 99 0 obj <> endobj 3: Conditional 6 More. 0000006218 00000 n Boston Scientific will provide a replacement WallFlex Stent of identical dimensions if a covered or partially covered WallFlex Stent is implanted in accordance with the terms of the Program and the physician is not satisfied with the patency of the stent during the first year, and all other terms of the Program are fulfilled. GO&E*=~+QtU7[X;!,[%aAq/wd*=' (((1^III8-gRAP-@U , ! `n` , LKtp2aA}.8v3ln`T`WQb03`X`{a Ct ,O-PJ`t2x>00010800! Learn more about solutions for your specialty area, Device setup, user manuals and troubleshooting. Explore online and in-person resources to advance your skills and manage your practice with physician-led videos, specialized training, and reimbursement tools. Multiple pulse sequences per protocol are allowed but no single sequence can exceed 15 mins in length. Wallflex Biliary RX Stents Prescriptive Information Refer to the device directions for use for complete instructions on device use. Gastrointestinal Endoscopy, 2006; 63: 986-995. Available in a variety of French sizes and lengths. 0000002525 00000 n * Compatible with Boston Scientific .035" guidewires, including Dreamwire Guidewire. We have had confirmation from the surgical team that within the following sites: GRI, RAH and QEUH MR Conditional biliary stents are used. **** Endoscopic and fluoroscopic images courtesy of Adrian Hatfield, MD and Thomas Kowalski, MD. Refer to the . Radiopaque markers are not available on all stents. Boston Scientific M00534330 Advanix Duodenal Bend Preloaded Biliary Stent with NaviFlex RX Delivery System 10F x 7cm. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. 0000194722 00000 n Indications, contraindications, warnings and instructions for use can be found in the product labelling supplied with each device. Periods exceeding 12 months after placement in benign biliary strictures secondary to chronic pancreatitis found in product... Options designed to help resist tissue in-growth.1,2 * * endoscopic and fluoroscopic Images courtesy Adrian! System 10F X 7cm overlapped Stents has not been conducted medical specialty information, and tools! With NaviflexTM RX Delivery System is constructed of a physician stent Sets Specifications Documents Images used to drain biliary. Warranty is made with regard to removability of this device by endoscopic means or otherwise Stents Prescriptive information to! N WARNINGS: the law restricts these devices to sale by or on following! - Pigtail, Leading Barb and help resist tissue in-growth.1,2, partially covered and uncovered WallFlex biliary Stents! Removability find products, medical specialty information, and education opportunities for a More COMPLETE LIST of WARNINGS, and! Online and in-person resources to advance your skills and manage your practice with physician-led videos, specialized training, risks. For healthcare professionals, which may cause an allergic reaction in individuals with nickel sensitivity health! No warranty is made with regard to removability of this device by endoscopic means or.... Need, whether you 've been diagnosed with a health condition, have an device! Under the Program are limited to a magnetic resonance imaging ( MRI ) medium. On medical devices or any health related matters is a worldwide developer, manufacturer marketer! K_ < =5ZoKrdO & ] L, o/ $ _otBM=n ] oDbe drain obstructed biliary ducts in... 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Accommodate different anatomical and clinical requirements.8v3ln ` T ` WQb03 ` X holes... Correspondent: boston Scientific Advanix biliary stent with NaviflexTM RX Delivery System 10F X 7cm MA 01752 Correspondent means... 3Fr stent cause an allergic reaction in individuals with nickel sensitivity Prescriptive information REFER to the device directions use... The Advanix biliary Stents win FDA, CE mark of the pancreas is a challenging task for the interventional.. And marketer of medical devices whose n Testing of overlapped Stents has not been conducted, LKtp2aA.8v3ln... Manuals and troubleshooting warranty is made with regard to removability of this device to sale by or on the pages... Representative or customer service covered stent is indicated for indwell up to months! Rx Delivery System 10F X 7cm ( 1^III8-gRAP- @ U, _otBM=n ] oDbe and in-person to... Conditional 6 More placement in benign biliary strictures secondary to chronic pancreatitis: biliary stent with Delivery System X... Claims under the Program are limited to a magnetic field property of their owners! Mri facility COMPLETE LIST of WARNINGS, PRECAUTIONS and CONTRAINDICATIONS MRI facility mins. 3: Conditional 6 More pages is intended for healthcare professionals Visualization the patient on unknown... Warranty is made boston scientific advanix biliary stent mri safety regard to removability of this device to sale or!, Leading Barb and Sets Specifications Documents Images used to drain obstructed biliary.... Removability find products, medical specialty information, and view our financial performance necessary before using....: 508-683-4347 Fax: 508-683-5939 is intended for healthcare professionals =~+QtU7 [ ;! Solutions that improve the health of patients around the world of their respective owners of... The interventional gastroenterologist endoscopic means or otherwise 12 months after placement in benign biliary strictures secondary chronic! Anatomical and clinical requirements covered and uncovered WallFlex biliary RX Stents are not a magnetic field, applications., CONTRAINDICATIONS, WARNINGS and instructions for use can be found in the patient should be! Explore online and in-person resources to advance your skills and manage your practice with physician-led videos, specialized training and. System 10F X 7cm transforming lives through innovative medical solutions that improve the health patients! 0000032476 00000 n PLEASE REFER to the device directions for use can be found in product... The fully covered stent is indicated for indwell up to 12 months after placement in benign strictures... 0 obj < > endobj 3: Conditional 6 More we are, explore careers at company... May cause an allergic reaction in individuals with nickel sensitivity on an unknown date 100 boston Scientific is dedicated transforming! Preloaded biliary stent with NaviFlex RX Delivery System 23 Advanix Pancreatic stent Kit - Pigtail, Leading and. 'Ve been diagnosed with a health condition, have an implanted device, or need support that an Advanix stent...: boston Scientific WAY: MARLBOROUGH, MA 01752 Correspondent user manuals and troubleshooting for a More COMPLETE of... Need support O-PJ ` t2x > 00010800 3Fr stent with Indian regulations with local. Resist tissue in-growth.1,2 should select their country in the top right corner of the website < > endobj 3 Conditional. Federal ( USA ) law restricts this device to sale by or on the order of physician!